a study to evaluate the efficacy of investigational otc eye drops

Conditions: Ophthalmic Solutions

Summary: this is a single center, double-blinded study designed to demonstrate the therapeutic equivalence of over-the-counter eye drops in healthy adults with red eyes.

eligible participants will use assigned eye drop products as directed. participants will be required to attend 2 consecutive clinic visits. assessments for eye redness and eye comfort will be completed. participants will complete brief questionnaires about their eyes.

Eligibility criteria:
inclusion criteria: 1. able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment; 2. able and willing to provide a signed and dated informed consent document and authorization for the release of health information for research 3. male or female of any race or ethnicity, aged 18 years and older; 4. females of childbearing potential who have a negative urine pregnancy test at the screening/baseline visit (visit 1); 5. able to read and understand english; 6. healthy subjects with redness in both eyes 7. history of topical ocular drugs or desire to use within the last 6 months; 8. ocular health within normal limits, 9. male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. females must have used such birth control for at least 3 months prior to the screening/baseline visit 1. exclusion criteria: 1. suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates); 2. known sensitivity, allergy or contraindications to any investigational product ingredient; 3. females who are pregnant, planning to become pregnant or breastfeeding during the study; 4. subjects who were previously screened and determined to be ineligible for the study; 5. use of a therapeutic eye treatment (over-the-counter or prescription) within 2 days of the screening/baseline visit (visit 1) and throughout study participation; 6. participation in any clinical study investigation within 30 days of screening/baseline visit (visit 1); 7. relative, partner or staff of any clinical research site personnel; 8. active infection of any type at the start of the study; particularly, presence of active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection; 9. any ocular condition that could affect the subject's safety or trial parameter, such as severe ocular allergy; 10. planned surgery during the trial period, 6 months prior to clinic visit 1 or 30 days after the end of study period; 11. has a compromised immune system; 12. has any acute or chronic, medical or psychiatric conditions 13. contact lens use within 24 hours prior to clinic visit 1 and during their participation in the study; 14. saline eye drop use within 24 hours prior to clinic visit 1 and during their participation in the study; 15. use of any new otc or prescription medications within 24 hours prior to clinic visit 1 and throughout study participation.

Keywords: eye redness eye comfort red eyes